Reconstitution device

Abstract

A reconstitution device for constituting a drug in a standard drug vial with a liquid in a second container such as a parenteral solution container is provided. The reconstitution device 10 includes a housing 52 and a hollow, double-pointed needle 54 mounted within the housing. The housing includes a sheath 70 having a substantially circular base 72 and a skirt 74 depending from the base. The skirt 72 includes a free end 76, a substantially cylindrical inner surface 78 and an outer surface 80. A plurality of inwardly projecting bumps 82 are intermittently spaced about the inner surface 78. The bumps are disposed a substantially equal distance from the base 72, the distance being substantially equal to the width of the malleable band.

What is claimed is: 
     
       1. A device for reconstituting a drug in a drug vial, the vial having a mouth with a malleable band thereabout, said device comprising: A. a sheath including: (i) a substantially circular base,   (ii) a semi-flexible skirt depending from said base, said skirt including a free end, a substantially cylindrical inner surface and an outer surface and   (iii) a plurality of inwardly projecting bumps intermittently spaced about said inner surface, said bumps all being disposed a substantially equal distance from said base, said distance being substantially equal to the width of the malleable band,   (iv) wherein each of said bumps includes a sloped side facing said free end;     B. means for entering the drug vial, mounted to said base and disposed within the cylindrical volume defined by said skirt;   C. means for entering the interior of a second container, connected to said base; and   D. flow path means for placing the interiors of the drug vial and the second container in open communication;   E. whereby upon installation of said sheath about the mouth of the drug vial, said bumps deform the sidewall of the malleable band and create a stop against the underside of the malleable band, making difficult the inadvertent disconnection of said device and the vial.   
     
     
       2. The device as in claim 1, wherein said means for entering the drug vial and a portion of said flow path means comprises a rigid, hollow, pointed needle mounted in said base. 
     
     
       3. The device as in claim 1, wherein said means for entering the second container and a portion of the flow path means comprises a rigid, hollow, pointed needle connected to said base. 
     
     
       4. The device as in claim 1, wherein said vial entering means, said second container entering means and said flow path means comprise a rigid, hollow needle having two pointed ends, said needle being secured between said ends to said base. 
     
     
       5. The device as in claim 1, wherein the second container is a parenteral solution container having an injection site. 
     
     
       6. The device as in claim 5, further comprising means for securing the device to the second container, about the injection site thereof. 
     
     
       7. The device as in claim 1, wherein at least said skirt comprises a polypropylene material. 
     
     
       8. The device as in claim 1, wherein at least said skirt comprises polyester material including a rubber modifier. 
     
     
       9. The device as in claim 8, wherein said skirt further comprises a material including a mold release agent. 
     
     
       10. The device as in claim 1, comprising at least three of said bumps. 
     
     
       11. The device as in claim 1, comprising five of said bumps. 
     
     
       12. The device as in claim 1, wherein each of said bumps includes a tip facing said free end and is wider at a point of maximum internal projection than at said tip. 
     
     
       13. The device as in claim 1, wherein said sloped side is at an angle of about 30 degrees from said inner surface. 
     
     
       14. The device as in claim 1, wherein each of said sloped sides defines a convex surface across the width of said bump.